The following data is part of a premarket notification filed by Codonics, Inc. with the FDA for Codonics Np-1660 Series Medical Printers, Model 1660.
| Device ID | K003481 |
| 510k Number | K003481 |
| Device Name: | CODONICS NP-1660 SERIES MEDICAL PRINTERS, MODEL 1660 |
| Classification | Camera, Multi Format, Radiological |
| Applicant | CODONICS, INC. 16303 PANORAMIC WAY San Leandro, CA 94578 |
| Contact | Gary J Allsebrook |
| Correspondent | Gary J Allsebrook CODONICS, INC. 16303 PANORAMIC WAY San Leandro, CA 94578 |
| Product Code | LMC |
| CFR Regulation Number | 892.2040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-09 |
| Decision Date | 2001-01-19 |